Acute Respiratory Viral InfectionsPhase 4NCT03039621
Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children
A Phase 4 study testing Ergoferon in people with Acute Respiratory Viral Infections, run by Materia Medica Holding at 13 sites in 2 countries.
Trial summary
The international multicenter double-blind placebo-controlled randomized clinical study in parallel groups.The objective of this study is to obtain additional data on the efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children aged from 6 months to 6 years old. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Acute Respiratory Viral Infections
- What is being tested?
- Ergoferon
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 7 Oct 2016to 9 Jan 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of both genders aged from 6 months to 6 years old.
- ARVI based on medical examination: oral temperature of at least 38.0°C at examination + total symptom severity ≥5.
- The first 24 hours after ARVI onset.
- Seasonal raise in ARVI incidence.
- Availability of signed information sheet for parents/adopters(Informed Consent Form) for participation in the clinical trial.
Who cannot join
- Suspected pneumonia or bacterial infection (e.g. meningitis, sepsis, otitis media, urinary tract infection, etc.) requiring a prescription of antibacterial product from the first day of the disease.
- Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic diseases of connective tissue, oncohaematological and other diseases).
- Clinical symptoms of severe influenza infection/ARVI requiring hospitalization.
- Medical history of primary and secondary immunodeficiency; oncologic conditions.
- Aggravation or decompensation of chronic disease (diabetes mellitus, cerebral palsy, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ETN organs/ear, throat, mouth, tongue, larynx, trachea, neck and salivary and thyroid glands, etc.) which affect the patient's ability to participate in the clinical study.
- Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
Show all 12Show fewer
- Allergy/hypersensitivity to any components of the drug product used in the therapy.
- Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.
- Patients whose parents/adoptive parents will not fulfil the requirements during the study or follow the order of administration of the studied drug products from the investigator's point of view.
- Participation in other clinical trials within 3 months prior to the enrollment in this study.
- The patient's parent/adoptive parent is a study specialist at the centre and is directly involved in the study or is an immediate family member of the investigator. Spouses parents, children or siblings, regardless of whether they are siblings or adopted are considered immediate family members.
- The patient's parent/adoptive parent works at OOO "NPF "MATERIA MEDICA HOLDING", i.e. they are employees of the Company, temporary employees on a contract basis or appointed official responsible for conduction of the study or their immediate family members.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Russia10 sites
Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation
Kazan', 420012
Federal State Budgetary Educational Institution of Higher Education "Pirogov Russian National Research Medical University" of the Ministry of Healthcare of the Russian Federation
Moscow, 117997
Limited Liability Company "Diagnostics and Vaccines"
Moscow, 129515
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
Moscow, 192071
Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
Perm, 614066
State Budgetary Institution of Healthcare of the Samara Region "Samara City Children's Clinical Hospital named after N.N. Willow New
Samara, 443079
Volgograd State Medical University
Volgograd, 400131
Yaroslavl State Medical University/Children's Clinic # 5
Yaroslavl, 150000
Yaroslavl State Medical University/Clinical Hospital # 8
Yaroslavl, 150000
Municipal autonomous institution "Children's City Clinical Hospital №11"
Yekaterinburg, 620028
Kazakhstan3 sites
Kazakh Medical Continuing Education University
Almaty, 050057
Astana Medical University
Astana, 010000
Karaganda State Medical University
Karaganda, 100000
About this study
Official title: International Multicenter Double-blind Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children
The international multicenter double-blind placebo-controlled randomized clinical study in parallel groups.The objective of this study is to obtain additional data on the efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children aged from 6 months to 6 years old.
Read the detailed description
Study design: international, multicenter double-blind placebo-controlled randomized clinical study in parallel groups.
The study will enroll patients of either gender aged from 6 months to 6 years old with clinical manifestations of ARVI within the first days after the onset of the disease. Patients will be included evenly (1:1 ratio) in accordance with the age group: 6 months - 3 years 11 months 29 days; 4 years - 6 years 11 months 29 days. Signed information sheet for parents/adopters (inform consent form) will be obtained from all participant's parents/ adopters prior to the screening procedures. Medical history, thermometry, patient examination by the doctor, assesment of ARVI symptoms severity and nasopharyngeal swabswill be performed at screening visit (Day 1).
If the inclusion criteria are met and exclusion criteria are absent, the patient is included in the study.
Nasopharyngeal swabs will be analyzed by real-time reverse transcription polymerase chain reaction (RT-PCR) to identify the most common respiratory viruses, including (1) Influenza A virus; (2) Influenza B virus; (3) Influenza A (H1N1)pdm; (4) Human metapneumovirus; (5) Human respiratory syncytial virus; (6) Human rhinovirus; (7) Human adenovirus; (8) Human bocavirus; (9) Human parainfluenza virus 1; (10) Human parainfluenza virus 2; (11) Human parainfluenza virus 3; (12) Human parainfluenza virus 4; (13) Human coronavirus OC43; (14) Human coronavirus 229E; (15) Human coronavirus HKU1; (16) Human coronavirus NL63.
The patients are randomized into one of two groups: the 1st group patients will take Ergoferon according to the dosage regimen for 5 days; the 2nd group patients will take Placebo according to the dosage regimen of Ergoferon for 5 days. Patient's parents/ adoptive parents are provided with diares, where daily in the morning and at hight they record oral temperature (measured by a digital thermometer provided by Sponsor), symptoms of ARVI (according to the 4-points scale), administered drug and concomitant therapy. The doctors instruct parents/ adoptive parents how to fill in the diaries; the first scores of ARVI symptoms severity and oral temperature are made by doctors together with the parents/adoptive parents.
Patients are observed up for 14 days (screening and randomization - up to 1 day, therapy for 5 days, follow-up from 6 to 10 days; delayed telephone "visit" - on day 14).
During the observation period, two visits are planned (at home or at the medical center) on day 3 (Visit 2) and day 6 (Visit 3). If patients still have any symptoms of ARVI/ complications of ARVI, then an additional (unscheduled) Visit 4 is provided on Day 10 of the observation (at the medical center). During Visits 2, 3 (4), doctors carry out an physical examination, record dynamics of ARVI symptoms and concomitant therapy, check patient's diaries, which parents/adoptive parents return back at Visit 3 or 4. At Visit 3 (after 5 days of therapy) compliance with the treatment is additionally assessed. A "telephone visit" (Visit 5, Day 14 ± 1) is carried out to interview parents about the patient's condition, presence/ absence of complications, and possible use of antibiotics.
During the study, symptomatic therapy and therapy for underlying chronic conditions are allowed with the exception of the drugs indicated in the section "Prohibited Concomitant Therapy".
- Conditions
- Acute Respiratory Viral Infections
- Being tested
- Ergoferon, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgoferonDrug
For oral use.
PlaceboDrug
For oral use.
| Study group | Role | What they receive |
|---|---|---|
| Ergoferon | Experimental | Tablet for oral use, 1 tablet per intake (outside a meal/feeding). On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day (total 8 tablets). From day 2, one tablet is taken every 8 hours. The drug is administered outside a meal (in the interval between meals or 15 minutes before meal or fluid intake). Keep the tablet in the mouth, without swallowing, until completely dissolved. For young children (aged 6 months to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature. The therapy lasts for 5 days. Receives: Drug: Ergoferon |
| Placebo | Placebo comparator | Placebo using Ergoferon scheme. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Alleviation of All ARVI Symptoms.
Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.
Measured: 14 days of observation.
Secondary outcomes (8)
Time to Normalization of Body Temperature.
Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).
Measured: 14 days of observation.
Time to Alleviation of Flu-like Nonspecific Symptoms.
Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.
Measured: 14 days of observation.
Time to Alleviation of Respiratory Symptoms.
Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.
Measured: 14 days of observation.
Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.
Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.
Measured: On days 2-6 of the observation period.
ARVI Severity.
Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent a worse outcome.
Measured: On days 2-6 of the observation period.
Percentage of Recovered Patients.
Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).
Measured: On days 2-6 of the observation period.
Rates of Antipyretics Use Per Patient.
Based on patient diary data. The number of intakes of prescribed antipyretics.
Measured: On days 1- 5 of the treatment period.
Percentage of Patients With Worsening of Illness.
Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).
Measured: 14 days of observation peiod.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start7 Oct 2016
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Respiratory Viral InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039621
- Sponsor's protocol ID
- MMH-ER-009
- Status last verified
- May 2019
- First submitted
- 28 Dec 2016
- Last updated
- 27 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Double-blind Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Acute Respiratory Viral Infections in Children
- ClinicalTrials.gov ID
- NCT03039621
- Acronym / sponsor ID
- MMH-ER-009
- Conditions
- Acute Respiratory Viral Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2016 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Posted 27 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The international multicenter double-blind placebo-controlled randomized clinical study in parallel groups.The objective of this study is to obtain additional data on the efficacy and safety of Ergoferon in the treatment of acute respiratory viral infections (ARVI) in children aged from 6 months to 6 years old.
Detailed description
Study design: international, multicenter double-blind placebo-controlled randomized clinical study in parallel groups.
The study will enroll patients of either gender aged from 6 months to 6 years old with clinical manifestations of ARVI within the first days after the onset of the disease. Patients will be included evenly (1:1 ratio) in accordance with the age group: 6 months - 3 years 11 months 29 days; 4 years - 6 years 11 months 29 days. Signed information sheet for parents/adopters (inform consent form) will be obtained from all participant's parents/ adopters prior to the screening procedures. Medical history, thermometry, patient examination by the doctor, assesment of ARVI symptoms severity and nasopharyngeal swabswill be performed at screening visit (Day 1).
If the inclusion criteria are met and exclusion criteria are absent, the patient is included in the study.
Nasopharyngeal swabs will be analyzed by real-time reverse transcription polymerase chain reaction (RT-PCR) to identify the most common respiratory viruses, including (1) Influenza A virus; (2) Influenza B virus; (3) Influenza A (H1N1)pdm; (4) Human metapneumovirus; (5) Human respiratory syncytial virus; (6) Human rhinovirus; (7) Human adenovirus; (8) Human bocavirus; (9) Human parainfluenza virus 1; (10) Human parainfluenza virus 2; (11) Human parainfluenza virus 3; (12) Human parainfluenza virus 4; (13) Human coronavirus OC43; (14) Human coronavirus 229E; (15) Human coronavirus HKU1; (16) Human coronavirus NL63.
The patients are randomized into one of two groups: the 1st group patients will take Ergoferon according to the dosage regimen for 5 days; the 2nd group patients will take Placebo according to the dosage regimen of Ergoferon for 5 days. Patient's parents/ adoptive parents are provided with diares, where daily in the morning and at hight they record oral temperature (measured by a digital thermometer provided by Sponsor), symptoms of ARVI (according to the 4-points scale), administered drug and concomitant therapy. The doctors instruct parents/ adoptive parents how to fill in the diaries; the first scores of ARVI symptoms severity and oral temperature are made by doctors together with the parents/adoptive parents.
Patients are observed up for 14 days (screening and randomization - up to 1 day, therapy for 5 days, follow-up from 6 to 10 days; delayed telephone "visit" - on day 14).
During the observation period, two visits are planned (at home or at the medical center) on day 3 (Visit 2) and day 6 (Visit 3). If patients still have any symptoms of ARVI/ complications of ARVI, then an additional (unscheduled) Visit 4 is provided on Day 10 of the observation (at the medical center). During Visits 2, 3 (4), doctors carry out an physical examination, record dynamics of ARVI symptoms and concomitant therapy, check patient's diaries, which parents/adoptive parents return back at Visit 3 or 4. At Visit 3 (after 5 days of therapy) compliance with the treatment is additionally assessed. A "telephone visit" (Visit 5, Day 14 ± 1) is carried out to interview parents about the patient's condition, presence/ absence of complications, and possible use of antibiotics.
During the study, symptomatic therapy and therapy for underlying chronic conditions are allowed with the exception of the drugs indicated in the section "Prohibited Concomitant Therapy".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergoferon | Experimental | Drug: ErgoferonTablet for oral use, 1 tablet per intake (outside a meal/feeding). On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day (total 8 tablets). From day 2, one tablet is taken every 8 hours. The drug is administered outside a meal (in the interval between meals or 15 minutes before meal or fluid intake). Keep the tablet in the mouth, without swallowing, until completely dissolved. For young children (aged 6 months to 3 years old), the tablet is recommended to be dissolved in a small amount (1 tablespoon) of drinking water of room temperature. The therapy lasts for 5 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo using Ergoferon scheme. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients of both genders aged from 6 months to 6 years old.
- ARVI based on medical examination: oral temperature of at least 38.0°C at examination + total symptom severity ≥5.
- The first 24 hours after ARVI onset.
- Seasonal raise in ARVI incidence.
- Availability of signed information sheet for parents/adopters(Informed Consent Form) for participation in the clinical trial.
Key exclusion criteria (12 listed)
- Suspected pneumonia or bacterial infection (e.g. meningitis, sepsis, otitis media, urinary tract infection, etc.) requiring a prescription of antibacterial product from the first day of the disease.
- Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic diseases of connective tissue, oncohaematological and other diseases).
- Clinical symptoms of severe influenza infection/ARVI requiring hospitalization.
- Medical history of primary and secondary immunodeficiency; oncologic conditions.
- Aggravation or decompensation of chronic disease (diabetes mellitus, cerebral palsy, cystic fibrosis, primary ciliary dyskinesia, bronchopulmonary dysplasia, malformations of the respiratory and ETN organs/ear, throat, mouth, tongue, larynx, trachea, neck and salivary and thyroid glands, etc.) which affect the patient's ability to participate in the clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErgoferonFor oral use. | Drug | Ergoferon |
| PlaceboFor oral use. | Drug | Placebo |
Primary outcome
Time to Alleviation of All ARVI Symptoms.
Time frame: 14 days of observation.
Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom). TS ranges from 0 to 30, and the higher scores mean a worse outcome.
8 secondary outcomes
Time to Normalization of Body Temperature.
Time frame: 14 days of observation.
Time to Alleviation of Flu-like Nonspecific Symptoms.
Time frame: 14 days of observation.
Time to Alleviation of Respiratory Symptoms.
Time frame: 14 days of observation.
Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.
Time frame: On days 2-6 of the observation period.
ARVI Severity.
Time frame: On days 2-6 of the observation period.
Percentage of Recovered Patients.
Time frame: On days 2-6 of the observation period.
Rates of Antipyretics Use Per Patient.
Time frame: On days 1- 5 of the treatment period.
Percentage of Patients With Worsening of Illness.
Time frame: 14 days of observation peiod.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ergoferon in people with Acute Respiratory Viral Infections, run by Materia Medica Holding at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Russia, Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Alleviation of All ARVI Symptoms. (time frame: 14 days of observation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.